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Chronic Subdural Hematoma Treatment With Embolization Versus Surgery Study

Recruiting

Who can join

Ages 40 to 90 · All sexes

Full eligibility criteria
Inclusion Criteria:

1. Age 40-90 years inclusively.
2. Per CT of the head, (one of the following): Unilateral convexity CSDH measuring at least 10 mm in thickness OR Bilateral CSDH if only one side is considered for treatment (at least 10 mm in thickness) and the contralateral side is asymptomatic and \< 10 mm in thickness.
3. CSDH at least 2/3 isodense or hypodense, verified on axial CT slice used to measure the thickness of the qualifying CSDH.
4. Qualifying baseline head CT performed within the 7 days prior to randomization.
5. Able to undergo assigned treatment within 72 hours after randomization.
6. Patient or legally authorized representative agrees to be randomized, and provides written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization.

Exclusion Criteria:

1. Secondary cause apart from trauma for the qualifying SDH, such as an underlying vascular abnormality or tumor.
2. Tentorial or interhemispheric SDH.
3. Secondary to CSDH, MRC of 0, 1, 2, or 3 in any muscle group contralateral to the side of the CSDH 4.
4. Pre CSDH mRS of 5 or higher.
5. Secondary to CSDH, patient is unable to complete TUG (i.e.,TUG \> 120 seconds, unable to walk, or tries TUG but quits in ≤ 120 seconds). Note: This criterion does not apply if the patient does not complete TUG for reason other than CSDH.
6. Secondary to CSDH, ASR of 0, 1, or 2.
7. Emergent surgical evacuation such as open craniotomy, burr hole drainage, or Subdural Evacuating Port System (SEPS) is required for the patient.
8. Unable to withhold all antiplatelet agents or OACs for the first 7 days after randomization.
9. Indication that withdrawal of care will be implemented for the qualifying SDH.
10. Prior surgical treatment for CSDH if the surgery is less than 30 days prior to randomization.
11. On tranexamic acid.
12. Platelet count of \<100,000 per microliter refractory to transfusion.
13. Coagulopathy that cannot be corrected to an INR of ≤1.5.
14. Known contraindications to angiography.
15. Known intolerance to occlusion procedures.
16. Known vascular anatomy (small artery size) or blood flow (high vascular resistance peripheral to the feeding arteries) that precludes catheter placement or embolic agent (Embosphere Microspheres or CONTOUR particles) injection.
17. Known presence of collateral vessel pathways potentially endangering normal territories or cranial nerves during embolization.
18. Known large diameter arteriovenous shunt, i.e., where the blood does not pass through an arterial/capillary/venous transition but directly from an artery to a vein or presence of patent extra-to-intracranial anastomoses (where study embolization devices could pass directly into the internal carotid artery, vertebral artery, or intracranial vasculature) that cannot be addressed with coil embolization.
19. Patient has a known active systemic infection or sepsis.
20. Patient is pregnant, planning to become pregnant, or lactating.
21. Life expectancy of less than 6 months due to comorbid terminal conditions.
22. Concurrent participation in another research protocol for investigation of an experimental therapy.
23. Known or suspected to not be able to comply with the study protocol.
24. For unilateral CSDH, no measurable deficit secondary to the CSDH on the Timed Up and Go \[TUG\], Aphasia Severity Rating \[ASR\], or MRC. At baseline, a measurable deficit on the TUG is defined as: time ≥10 seconds. At baseline, a measurable deficit on the ASR is defined as: a score ≤4. At baseline, a measurable deficit on the MRC is defined as: a score \< 5 in any muscle group contralateral to the site of the CSDH.
25. For bilateral CSDH, no measurable deficit secondary to the treatment-eligible CSDH on the ASR or MRC. At baseline, a measurable deficit on the ASR is defined as: a score ≤4. At baseline, a measurable deficit on the MRC is defined as: a score \< 5 in any muscle group contralateral to the treatment-eligibile CSDH side.

About the study

The goal of this clinical trial is to test in moderately symptomatic chronic subdural hematoma (CSDH) patients if middle meningeal artery embolization (MMAE) can be used as an alternative to conventional open surgery. The main questions it aims to answer are:

* Compared to open conventional surgery, does MMAE reduce the need for rescue surgery or deaths? * What is the safety of MMAE and conventional open surgery in these patients?

Participants will be asked to:

* Share their medical history and undergo physical examinations * Have blood drawn * Have CT scans of the head * Answer questionnaires * Undergo MMAE or conventional open surgery * Provide information about possible adverse events Researchers will compare participants in the MMAE group with those in the conventional open surgery group to see if there is a reduced need for rescue surgery or deaths and evaluate safety.

What is being tested

Sponsor: The University of Texas Medical Branch, Galveston · Participants: 520 · Started: Nov 1, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06347796

Locations in the U.S.

ArizonaMayo Clinic Arizona, Phoenix
FloridaBaptist Medical Center Jacksonville, Jacksonville
University of Miami Miller School of Medicine, Miami
University of South Florida, Tampa
GeorgiaEmory University, Atlanta
KansasUniversity of Kansas Medical Center, Kansas City
MassachusettsBeth Israel Deaconess Medical Center, Boston
Brigham and Women's Hospital, Boston
Massachusetts General Hospital, Boston
MissouriUniversity of Missouri Healthcare, Columbia
Washington University, St. Louis, St Louis
New JerseyCooper University Hospital, Camden
JFK Neuroscience Institute, JFK University Medical Center, Edison
Rutgers, The State University of New Jersey, Newark
New YorkIchan School of Medicine at Mount Sinai, New York
Montefiore Medical Center, The Bronx
Westchester Medical Center, Valhalla
North CarolinaWake Forest University, Winston-Salem
OhioGood Samaritan Hospital, Cincinnati
Mercy Health St. Vincent Medical Center, Toledo (Not yet recruiting)
PennsylvaniaUniversity of Pennyslvania, Philadelphia
Philadelphia Neurological Institute, Upland
TexasUT Southwestern Medical Center, Dallas
University of Texas Medical Branch, Galveston
University of Texas Health Science Center-Houston, Houston
University of Texas Health Science Center-San Antonio, San Antonio
UtahUniversity of Utah, Salt Lake City
VirginiaUniversity of Virginia, Charlottesville
WashingtonUniversity of Washington, Seattle

Conditions

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.